iCardiac Applies Automated Approach to Thorough QT Study
for a Leading Pharmaceutical Company
Rochester, New York – October 21, 2008 –A leader in advanced cardiac safety analysis announced today that it has completed a highly automated analysis of ECG data for a leading pharmaceutical firm’s Thorough QT (TQT) study.
iCardiac Technologies, which provides advanced cardiac safety analysis for pharmaceutical and biotech companies in clinical research, analyzed approximately 9.4 million cardiac beats using its proprietary Thorough QT PlusSM tools . iCardiac’s highly automated approach addresses the high cost and long lead time of cardiac safety trials that use manual measurements exclusively. It is the first solution in the industry to comply with the FDA’s E14 guidance.
“iCardiac was selected by the sponsor for its strong scientific and medical team as well as its advanced ECG analysis capabilities, which have been recognized by top pharmaceutical companies as a way to decrease cost of TQT studies and gain deeper insight into the cardiac safety profile of drugs in development,” said iCardiac’s Co-Founder and Executive Vice President Sasha Latypova.
iCardiac’s highly automated QT technology combines advanced ECG signal processing algorithms developed over the past decade with a robust quality assurance process conducted by cardiologists. It has been validated in studies that show results equivalent to manual measurements performed independently by U.S. board-certified cardiologists.
iCardiac’s highly automated QT technology, which was presented this year to the FDA’s interdisciplinary review team (IRT) meeting, uses sophisticated statistical models and algorithms. It guides cardiologists to those ECGs that require attention and/or adjustment. Using this approach, only a portion of the entire Thorough QT (TQT) dataset requires manual over-reading, thereby generating significant cost savings to sponsors while at the same time providing assurance to the regulators as well as pharmaceutical companies regarding data quality.
About iCardiac Technologies
iCardiac Technologies, Inc. develops and implements advanced ECG-based cardiac safety biomarkers and tools. iCardiac’s advanced ECG-based cardiac safety analysis service stems from more than 30 years of research at the University of Rochester, a leading institution for ventricular arrhythmias and cardiac repolarization. iCardiac’s analysis service provides drug developers with more precise and cost-effective methods for QT interval measurement. In addition, it provides Beyond QT,sm a suite of advanced ECG-based cardiac safety markers that deliver a more accurate assessment the cardiac safety profile of drugs in development. For more information, visit: www.icardiac.com.